5 results
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26ms
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Sources: EU EUDAMED, US FDA
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Country: China
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Automatic Hematology Analyzer F-FW Fluorescent Dye
Device
EU IVDR
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Eu Ivd Class A
·Maccura Biotechnology Co., Ltd. ·On the market·32 countries
Automatic Hematology Analyzer F-FW Fluorescent Dye
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Maccura Biotechnology Co., Ltd. ·1 device
GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·July 2, 2025
Dehydroepiandrosterone sulfate(CLIA)、DHEA-S Calibrators
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·July 2, 2025